Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial (PROPHET-II)

Total Cardiovascular Solutions

Status and phase: Completed; Phase 4

Conditions: Occlusion of Artery

Treatments: Procedure: Ulnar artery compression

Study type: Interventional

Funder types: Other

Identifiers

NCT01564888

MIL/IMRC/TCC/TP/10/2010

Details and patient eligibility

About

Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.

Enrollment: 3,000 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients referred for diagnostic cardiac catheterization.

Exclusion criteria

• previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups, including a placebo group

Patent hemostasis

Placebo Comparator group

Description:

Patent hemostasis is the technique for radial artery hemostasis after transradial catheterization, with proactive attempt to maintain radial artery hemostasis and radial artery patency.

Treatment:

Procedure: Ulnar artery compression

Ulnar artery compression

Active Comparator group

Description:

Ulnar artery compression will involve radial artery hemostasis using patent hemostasis technique and compression of ulnar artery to the point of occluding flow, in an attempt to augment radial artery flow.

Treatment:

Procedure: Ulnar artery compression